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Exercise Intervention for Young Cancer Survivors

N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)
Age ≥ 15 and ≤ 39 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 6, 12, and 24
Awards & highlights

Study Summary

This trial will test the feasibility of a 12-week, individualized, prescribed, supervised exercise intervention in adolescent and young adult (AYA) cancer survivors.

Who is the study for?
This trial is for young cancer survivors aged 15-39 who finished chemotherapy at least three months ago. It's not for those with CNS tumors, Down's Syndrome, serious liver issues, heart failure, cardiovascular disease, or certain physical disabilities that prevent exercise.Check my eligibility
What is being tested?
The study tests a supervised exercise program tailored to individual needs of adolescent and young adult cancer survivors. The goal is to see if this improves their overall health and emotional well-being compared to typical outcomes without such intervention.See study design
What are the potential side effects?
Exercise programs are generally safe but can include muscle soreness, fatigue, and risk of injury if not properly supervised or if the participant overexerts themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had chemotherapy for at least three months, but I may be on hormone therapy.
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I am between 15 and 39 years old.
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I have had cancer in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 6, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 6, 12, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Balance Assessment
Change of Cancer Therapy Fatigue
Change of Cardiovascular Systems - FCV
+8 more
Secondary outcome measures
Adverse Event Pain Assessment
Beck Anxiety Inventory
Depression - BDI
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,094 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04265638 — N/A
Pediatric Cancer Research Study Groups: Exercise, Usual Care
Pediatric Cancer Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04265638 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04265638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the enrollment requirements for this trial inclusive of those aged sixty or older?

"Eligible candidates for this investigation must meet the age criteria of at least 15 years old and no more than 39."

Answered by AI

What objectives is this clinical trial attempting to reach?

"The primary aim of this medical trial, evaluated at baseline and time points 6, 12, and 24 weeks out is to assess the impact of the intervention on cardiovascular system capacity via VO2 Peak (mL·kg-1·min-1). Supporting objectives include evaluating shifts in patient depression as measured by Children's Depression Inventory (CDI), Beck Anxiety Inventory, and a Visual Analogue Scale for pain intensity."

Answered by AI

Are there any requirements for participation in this experiment?

"This research initiative is accepting 66 pediatric cancer patients, aged between 15 and 39. Crucially for entry into the trial, participants should have a history of cancer as well as at least 3 months free from cytotoxic chemotherapy (hormone therapy being allowed)."

Answered by AI

Does this clinical experiment currently have room for more participants?

"Affirmative. The clinical trial database indicates that recruitment for this medical study is in progress, having been posted on June 5th 2019 and last modified on June 23rd 2022. 66 volunteers are needed across the three participating sites."

Answered by AI

What is the total participant count for this medical investigation?

"Affirmative. Clinicaltrials.gov has recorded that this experiment is actively recruiting patients, beginning from June 5th 2019 and last updated on June 23rd 2022. 66 individuals between 3 test locations are necessary for the trial's completion."

Answered by AI
~0 spots leftby May 2024